JP2021514246A - 3D auxiliary material - Google Patents

Abstract

Stapling assemblies for use with surgical staplers and methods of making them are provided. Three-dimensional auxiliary materials for use with surgical stapled assemblies and methods thereof are also provided.

Description

A three-dimensional auxiliary material and a method for manufacturing the same are provided.

Surgical staplers are used in surgical procedures to close openings in tissues, blood vessels, conduits, shunts, or other objects or body parts associated with a particular procedure. The incision may be naturally occurring, such as in a blood vessel or in a visceral passage such as the stomach, or by forming a bypass or anastomosis with a tissue or vascular puncture, or tissue undergoing a stapled procedure. It may be formed by the surgeon during a surgical procedure, such as by incision.

Some surgical staplers required the surgeon to select the appropriate staples with the appropriate staple height for the tissue to be stapled. For example, surgeons could choose tall staples for use on thick tissue and short staples for use on thin tissue. However, in some situations, the stapled tissue does not have a consistent thickness and therefore the staples are unable to achieve the desired firing configuration at each staple site. As a result, it has not been possible to form the desired seal in or near all of the stapled sites, which allows blood, air, gastrointestinal fluids, and other fluids to pass through the unsealed sites. It becomes possible to exude.

Moreover, staples and other objects and materials that can be implanted with procedures such as staple fastening generally lack some properties of the tissue in which they are implanted. For example, staples and other objects and materials may lack the natural flexibility of the tissue in which they are implanted and therefore cannot withstand various intra-tissue pressures at the implantation site. This can lead to undesired tearing and thus leakage of tissue at or near the staple site.

Therefore, there is still a need for improved instruments and methods to address the current problems with surgical staplers.

Staple fastening assemblies are provided for use with surgical staplers.

In one exemplary embodiment, a stapled assembly is provided, which may include a body having a plurality of staples disposed therein.
Multiple staples may be configured to be deployed within the organization. The body can have a first end, a second end, and a longitudinal axis extending between them. The stapled assembly can also include a three-dimensional compressible auxiliary material formed from a matrix containing at least one molten bioabsorbable polymer. Auxiliary material may be configured to be releasably held on the body so that the auxiliary material can be attached to the tissue by multiple staples in the body. Auxiliary material can have a plurality of struts interconnected at a joint to form a lattice structure having a plurality of openings therein. The interoperability between the plurality of columns and the joint allows the auxiliary material to be compressed in a first predetermined direction and limits movement in a second direction different from the first predetermined direction. Geometric shapes that can be constructed in this way can be formed.

The joint can have various configurations. For example, the joint may be more flexible than multiple struts. In one embodiment, each joint can include a ball-shaped feature.

In some embodiments, the struts can each have a substantially rectangular cross-sectional shape that can be configured to limit movement in the second direction.

In one aspect, the second direction may traverse the first predetermined direction.

In another aspect, the geometry can be configured to limit the rotational movement of the auxiliary material around the axis of the auxiliary material perpendicular to the first predetermined direction.

In some embodiments, the plurality of struts may include a first stanchion, each of which may be substantially planar, and the first stanchions may extend in the same plane to each other in the first plane. it can. In such an embodiment, the plurality of struts may each include a second stanchion that may be substantially planar, and the second stanchions may extend in the second plane and coplanar to each other. it can. The second plane can be parallel to the first plane.

In certain embodiments, the auxiliary material can have a tissue contact surface and a body contact surface opposite the tissue contact surface. The tissue contact surface and the body contact surface can move toward each other in a first predetermined direction.

In some embodiments, the auxiliary material may include a plurality of connecting members capable of connecting at least a portion of adjacent joints to each other in order to increase the rigidity of the auxiliary material.

In one aspect, the auxiliary material can be configured to apply a stress ^{of at least about 3 g / mm 2} to the tissue stapled to the auxiliary material for at least 3 days when the auxiliary material is in the tissue-deployed state.

In another exemplary embodiment, a staple assembly can be provided that includes a body with multiple staples that are placed internally. Multiple staples may be configured to be deployed within the organization. The stapled assembly can also include a three-dimensional compressible auxiliary material formed from a matrix containing at least one molten bioabsorbable polymer. Auxiliary material may be configured to be releasably held on the body, allowing the auxiliary material to be attached to the tissue by multiple staples of the body. Auxiliary material can have multiple struts that form repeating units with geometric shapes that can be configured to facilitate unidirectional compression of the auxiliary material. In one embodiment, the stapled assembly can also include connecting members that extend in the same plane as the plurality of struts, the connecting members limiting the transverse movement of the auxiliary material for unidirectional compression. Can be configured to.

In one aspect, the auxiliary material can be configured to apply a stress ^{of at least about 3 g / mm 2} to the tissue stapled to the auxiliary material for at least 3 days when the auxiliary material is in the tissue-deployed state.

The plurality of columns can have various configurations. For example, each strut can include a neck-down area that can be configured to bend to allow the auxiliary material to compress. In one embodiment, the plurality of struts can be substantially spiral in shape.

In some embodiments, the struts can be interconnected at nodes and the repeating units can form a lattice structure. In such an embodiment, the plurality of struts can be formed of a first material and the nodes can be formed of a second material which may be more flexible than the first material.

In certain embodiments, the plurality of struts can each include a first stanchion that can be substantially planar, and the first stanchions can extend in the same plane to each other in the first plane. .. In such an embodiment, the plurality of struts may each include a second stanchion that may be substantially planar, and the second stanchions may extend in the second plane and coplanar to each other. it can. The second plane can be parallel to the first plane.

The present invention will be more fully understood by reading the following detailed description in conjunction with the accompanying drawings.
FIG. 6 is a perspective view of an exemplary embodiment of conventional surgical staple fastening and cutting instruments. It is a perspective view of the wedge thread of the staple cartridge of the surgical staple fastening and the dividing instrument of FIG. FIG. 1 is a perspective view of a knife and launch bar (“E-shaped beam portion”) of a surgical staple fastening and cutting instrument of FIG. FIG. 1 is a longitudinal sectional view of a surgical cartridge that may be placed inside a stapled and cutting instrument of FIG. FIG. 4 is a top view of staples in a non-launched (pre-deployment) configuration that may be placed inside a staple cartridge in the surgical cartridge assembly of FIG. FIG. 5 is a longitudinal sectional view of an exemplary embodiment of a surgical cartridge assembly having an auxiliary material attached to a cartridge deck. It is a schematic which shows the auxiliary material of FIG. 6 of the organization deployment state. FIG. 5 is a perspective view of an exemplary embodiment of an auxiliary material having a plurality of repeating units of interconnected struts. It is an enlarged view of the repeating unit of the auxiliary material shown in FIG. 8A obtained in 8B. It is a schematic diagram of the iterative unit of FIG. 8B in the uncompressed state. It is a schematic diagram of the iterative unit of FIG. 8B in the first compressed state. It is a schematic diagram of the repeating unit shown in FIG. 8B of the second compressed state. It is a figure of the graph of the relationship between the rigidity of an auxiliary material and compression. FIG. 5 is a perspective view of an exemplary embodiment of an auxiliary material having a plurality of interconnected struts and inner connection features. 11B is a perspective sectional view of the auxiliary material shown in FIG. 11A obtained in 11B. FIG. 5 is a perspective view of another exemplary embodiment of an auxiliary material having a plurality of interconnected struts and connecting members. 12B is an enlarged view of the repeating unit of the auxiliary material shown in FIG. 12A obtained in 12B. FIG. 5 is a perspective view of another exemplary embodiment of an auxiliary material having a plurality of struts of the first material interconnected at a joint or node of the second material. It is an enlarged view of the repeating unit of the auxiliary material shown in FIG. 13A obtained in 13B. FIG. 5 is a perspective view of yet another exemplary embodiment of an interconnected strut repeating unit having an end shape. FIG. 3 is a perspective view of an auxiliary material according to another embodiment having a plurality of columns and at least one stopping element. FIG. 5 is a perspective view of an exemplary embodiment of an auxiliary material having a plurality of struts that are substantially spiral in shape. FIG. 5 is a perspective view of another exemplary embodiment of an auxiliary material comprising a plurality of columns in the form of vertical columns of different lengths. It is the schematic of the auxiliary material shown in FIG. 17 of the height before compression. It is the schematic of the auxiliary material shown in FIG. 17 of the first compression height. It is the schematic of the auxiliary material shown in FIG. 17 of the second compression height. FIG. 5 is a side view of an exemplary embodiment of an auxiliary material comprising a plurality of columns in the form of vertical columns and curved columns. FIG. 19 is a graphical representation of the mechanical behavior of the auxiliary material shown in FIG. 19 over the compression range. FIG. 5 is a perspective view of another exemplary embodiment of an auxiliary material having a channel configured to receive a cutting element and having a tab for attaching the auxiliary material to a staple cartridge. It is an exemplary embodiment of a staple cartridge assembly having the auxiliary material shown in FIG. 21A attached to the cartridge body. It is an exemplary embodiment of an auxiliary material having a cross-linked member.

Specific representative embodiments will be described below so that the principles of structure, function, manufacture, and use of the instruments and methods disclosed herein are comprehensively understood. One or more of these embodiments are illustrated in the accompanying drawings. The instruments, systems, and methods described in detail herein and shown in the accompanying drawings are non-limiting exemplary embodiments, and the scope of the invention is defined solely by the claims. Those skilled in the art understand. The features illustrated or described in connection with one exemplary embodiment can be combined with the features of another embodiment. Such modifications and modifications shall be included within the scope of the present invention.

Further, in the present disclosure, components with similar references in embodiments generally have similar characteristics, and thus, in a particular embodiment, each component with similar references. The features are not always completely detailed. Additionally, to the extent that linear or circular dimensions are used in the disclosed system, instrument, and method descriptions, such dimensions are the types of shapes that can be used in combination with such systems, instruments, and methods. It is not intended to be limited. Those skilled in the art will recognize that dimensions corresponding to such linear and circular dimensions can be easily determined for any geometry. The size and shape of the system and instrument, and its components, are at least the anatomical structure of the object in which the system and instrument are used internally, the size and shape of the component in which the system and instrument are used together, and the system and instrument. May depend on the method and treatment used.

It will be appreciated that the terms "proximal" and "distal" are used herein with reference to a user, such as a clinician, holding the handle of the instrument. Other spatial terms such as "anterior" and "posterior" also correspond distally and proximally, respectively. It will also be further understood that spatial terms such as "vertical" and "horizontal" are used in the drawings for convenience and for clarity. However, surgical instruments are used in many orientations and positions, and these spatial terms are not intended to be limited and absolute.

A value or range can be expressed herein as "about" and / or "about" from one particular value to another. When such values or ranges are expressed, other embodiments disclosed include the listed specific values and / or from one particular value to another. Similarly, it is understood that when a value is expressed in an approximate form by the use of the preceding "about", many of the disclosed values are listed and that particular value forms another embodiment. There will be. It will also be further understood that there are many values to be disclosed and that each value is also disclosed herein as a value with "about" in addition to the value itself. In some embodiments, "about" can be used to mean, for example, within 10% of the listed values, within 5% of the listed values, or within 2% of the listed values.

For the purposes of explaining and defining this teaching, unless otherwise stated, the term "substantially" is used herein to be unique as it may result from any quantitative comparison, value, measurement, or other expression. Note that it is used to represent the degree of uncertainty. The term "substantially" is also used herein to describe the extent to which a quantitative expression can vary from the stated criteria without resulting in a change in the basic function of the object in question. To.

Surgical staple assemblies, methods of manufacture thereof and methods of tissue staple are provided. Generally, a staple assembly is provided having a body (eg, a staple cartridge or end effector body) in which a plurality of staples are placed. The stapled assembly also includes a three-dimensional compressible auxiliary material formed from a matrix containing at least one molten bioabsorbable polymer and configured to be releasably retained on the body. Auxiliary material can be held releasably on the body when the staples are deployed from the body into the tissue so that at least a portion of the auxiliary material can be attached to the tissue captured by the staples. As discussed herein, the adjunct material is used to compensate for changes in tissue properties such as changes in tissue thickness and / or tissue endoculture when the adjunct material is stapled to the tissue. It can be configured to promote. For example, the auxiliary material may be configured to apply a stress of ^{at least about 3 g / mm 2} to the tissue for at least 3 days when in tissue deployment (eg, when the auxiliary material is stapled to the tissue in vivo). ..

An exemplary staple assembly may include various features to facilitate the application of surgical staples, as described herein and shown in the drawings. However, it will be appreciated by those skilled in the art that the stapled assembly may contain only some of these features and / or various other features known in the art. The stapled assemblies described herein are only intended to represent certain exemplary embodiments. In addition, auxiliary materials are described in connection with surgical staple cartridge assemblies and do not need to be replaceable, while auxiliary materials are associated with reloading staples that are not cartridge base or surgical instruments of any type. Can be used.

FIG. 1 shows an exemplary surgical staple and cutting instrument 100 suitable for use with implantable aids. The surgical staple fastening and cutting instrument 100 shown includes a staple application assembly 106 or end effector with an anvil 102 pivotally connected to an elongated staple channel 104. The staple application assembly 106, at its proximal end, can be attached to an elongated shaft 108 forming the implementation portion 110. When the staple application assembly 106 is closed, or at least substantially closed, the embodiment 110 may exhibit a sufficiently small cross section suitable for inserting the staple application assembly 106 into the trocar. Instrument 100 is configured to staple and cut tissue, but surgical instruments configured to staple tissue but not cut tissue are also contemplated herein.

In various situations, the staple application assembly 106 can be operated by a handle 112 connected to an elongated shaft 108. The handle 112 is controlled by the user, eg, a rotary knob 114 that rotates the elongated shaft 108 and the staple application assembly 106 around the longitudinal axis of the elongated shaft 108, and a staple application assembly 106 that is pivoted in front of the pistol grip 118. A closure trigger 116 that can be closed can be included. For example, when the closure trigger 116 is clamped, the closure release button 120 may be presented on the outside of the handle 112, thereby pressing the closure release button 120 to unclamp the closure trigger 116 and staple application assembly 106. Can be opened.

The firing trigger 122 can be pivoted in front of the closing trigger 116, which allows the staple application assembly 106 to simultaneously cut and staple the tissue clamped therein. In various situations, multiple firing strokes may be used with the firing trigger 122 to reduce the amount of force required to be applied by the surgeon's hand per stroke. In certain embodiments, the handle 112 may include one or more rotary indicator wheels capable of displaying the progress of firing, such as the rotary indicator wheel 124. The manual launch release lever 126 allows the launch system to retract, if desired, before the complete launch movement is complete, and the launch release lever 126 locks and / or functions the launch system. If it disappears, the surgeon or other clinician can retract the launch system.

Further details regarding the Surgical Staple Fastening and Cutting Instrument 100 and other Surgical Staple Fastening and Cutting Instruments suitable for use with the present disclosure are described, for example, in US Pat. No. It is described in 9,332,984 and US Patent Application Publication No. 2009/090763. Moreover, surgical staples and cutting instruments need not include a handle, but instead, the disclosure is incorporated herein by reference in its entirety. Includes a housing configured to connect to a surgical robot or the like, as described in US Patent Application Publication No. 15 / 689,198 filed with Shelton et al. On August 29, 2017.

With reference to FIGS. 2 and 3, for example, a launch assembly such as the launch assembly 228 can be used with a surgical staple and cutting instrument such as the instrument 100 of FIG. The launch assembly 228 comprises a wedge thread 230 having a plurality of wedges 232 configured to deploy staples from a staple application assembly such as the staple application assembly 106 of FIG. 1 with an anvil such as the anvil 102 of FIG. It may be configured to advance into the tissue trapped between it and an elongated staple channel such as channel 104 in FIG. In addition, an E-beam portion 233 located at the distal portion of the launch assembly 228 may launch staples from the staple application assembly and place anvils against elongated staple channels during launch. The E-shaped beam portion 233 shown includes a pair of upper pins 234, a pair of intermediate pins 236 that may be along portion 238 of the wedge thread 230, and a lower pin or foot 240. The E-beam portion 233 can also include a sharp cut edge 242 configured to cut the captured tissue as the launch assembly 228 advances distally. In addition, the integrally molded, proximally projecting upper guide 244 and intermediate guide 246, which bracket mount each vertical end of the cut edge 242, sharpen the tissue prior to cutting. Tissue staging areas 248 may be further defined to assist in guiding to 242. The intermediate guide 246 is also used to engage and launch the staple application assembly by abutting the stepped central member 250 of the wedge thread 230, which can result in the formation of staples by the staple application assembly.

With reference to FIG. 4, the staple cartridge 400 can be used with surgical staple fastening and cutting instruments such as the surgical staple fastening and cutting instrument 100 of FIG. 1, and a plurality of staple bodies 402 and a plurality within the cartridge body 402. The staple cavity 404 can be included. The staples 406 can be reclaimably placed in each staple cavity 404. The staple 406 in the unlaunched (pre-deployment, unformed) configuration is shown in detail with reference to FIG. The staple cartridge 400 can also include a firing member and / or a cutting member, eg, a longitudinal channel that can be configured to receive an E-beam, such as the E-beam 233 of FIG.

Each staple 406 may include a crown (base) 406 _C and one or more legs 406 _L extending from the crown 406 _C. Prior to the deployment of the staple 406, the crown 406 _C of the staple 406 can be supported by a staple driver 408 located within the staple cartridge 400, while the legs 406 _L of the staple 406 are stapled. It can be at least partially contained within the cavity 404. Further, the staple leg 406 _L of the staple 406 can extend beyond the tissue contact surface 410 of the staple cartridge 400 when the staple 406 is in the unlaunched position. In certain situations, as shown in FIG. 5, _{the tip of the staple leg 406 L} can be sharp, which can incise and penetrate the tissue.

In some embodiments, the staples can include one or more external coatings, such as sodium stearate lubricant and / or antibacterial agent. The antibacterial agent may be applied to the staple as its own coating or incorporated into another coating such as a lubricant. Non-limiting examples of suitable antibacterial agents include 5-chloro-2- (2,4-dichlorophenoxy) phenol, chlorhexidine, silver formulations (such as nanocrystalline silver), ethyl lauric acid esters (LAE). ), Octenidin, polyhexamethylene biguanide (PHMB), taurolysin, lactic acid, citric acid, acetic acid, and salts thereof.

The staple 406 can be deformed from the unlaunched position to the launched position, whereby the leg 406 _L moves through the staple cavity 404 and is between the anvil and the staple cartridge 400, such as the anvil 102 in FIG. Penetrates the tissue placed in and makes contact with the anvil. When the leg 406 _L hits the anvil and deforms, the leg 406 _L of each staple 406 can capture a part of the tissue within each staple 406 and apply compressive force to this tissue. Further, the leg portion 406 _L of each staple 406 can be deformed downward toward the crown 406 _{C of the} staple 406 to form a staple capture region in which tissue can be captured internally. In various situations, the staple capture area can be defined between the inner surface of the deformed leg and the inner surface of the staple crown. The size of the staple capture area may depend on several factors, such as leg length, leg diameter, crown width, and / or degree of leg deformation.

When in use, an anvil such as the anvil 102 in FIG. 1 presses a closure trigger such as the closure trigger 116 in FIG. 1 to advance an E-shaped beam such as the E-beam 233 in FIG. , Can be moved to the closed position. The anvil can place the tissue relative to the tissue contact surface 410 of the staple cartridge 400. Once the anvils are properly placed, staples 406 can be deployed.

As mentioned above, to deploy the staple 406, a staple firing thread, such as thread 230 in FIG. 2, can move from the proximal end 400p towards the distal end 400d of the staple cartridge 400. As the launch assembly, such as the launch assembly 228 of FIG. 3, advances, the thread can contact the staple driver 408 and lift the staple driver 408 upwards inside the staple cavity 404. In at least one embodiment, the thread and staple driver 408 may each include one or more inclined surfaces, i.e., beveled surfaces, which may work together to move the staple driver 408 upward from an unlaunched position. it can. When the staple driver 408 is lifted upward in each staple cavity 404, the staple 406 advances upward and the staple 406 exits the staple cavity 404 and penetrates into the tissue. In various situations, the thread can move several staples upwards at the same time as part of the firing sequence.

Auxiliary materials are shown and described below, but the auxiliary materials disclosed herein can be used with other surgical instruments and do not need to be attached to staple cartridges as described. Those skilled in the art understand. Further, those skilled in the art will appreciate that the staple cartridges do not need to be replaceable.

As mentioned above, some surgical staplers often require the surgeon to select the appropriate staple with the appropriate staple height for the tissue to be stapled. For example, surgeons could choose tall staples for use on thick tissue and short staples for use on thin tissue. However, in some situations, the stapled tissue does not have a consistent thickness, so the staples are applied to all parts of the stapled tissue (eg, thick and thin tissue parts). On the other hand, the desired launch configuration cannot be achieved. Inconsistent tissue thickness also means that when staples of the same or substantial height are used, especially the staple site is exposed to internal pressure at the staple site and / or along the staple rows. When done, it can result in tissue leaking and / or tearing undesirably at the staple site.

Therefore, to avoid the need to consider the height of the staples when stapling the tissue during surgery, it compensates for the various thicknesses of tissue trapped within the launched (deployed) staples. Various embodiments of three-dimensionally printed staples that can be configured to do so are provided. That is, the auxiliary materials described herein are used to staple sets of staples of the same or similar height to tissues of varying thickness (ie, thin to thick). It can also be combined with ancillary materials to provide proper tissue compression within and between fired staples, while making this possible. Thus, the auxiliary materials described herein can maintain suitable compression for stapled thin or thick tissue, thereby preventing the tissue from leaking and / or tearing at the site of the staple. Can be minimized.

Alternatively or additionally, the three-dimensionally printed auxiliary material may be configured to promote tissue infestation. In various situations, into implantable aids to facilitate healing of the tissue to be treated (eg, stapled and / or incised tissue) and / or to accelerate patient recovery. It is desirable to promote tissue incision. More specifically, inoculation of tissue into implantable auxiliary materials can reduce the incidence, extent, and / or duration of inflammation at the surgical site. Intra-transplantation of tissue into and / or around implantable aids can, for example, control the spread of infection at the surgical site. Infection of blood vessels, especially leukocytes, in and / or around implantable auxiliary materials, for example, can counter infection in and / or around implantable auxiliary materials and adjacent tissues. Tissue endoculture can also aid the patient's body in accepting foreign bodies (eg, implantable aids and staples) and can reduce the likelihood that the patient's body will reject the foreign body. Rejection of foreign bodies can result in infection and / or inflammation at the surgical site.

Unlike traditional auxiliary materials (eg, non-three-dimensionally printed auxiliary materials, such as woven fabric auxiliary materials), these three-dimensionally printed auxiliary materials have a consistently reproducible microstructure (eg, woven fabric auxiliary materials). Can be formed in units). That is, unlike other manufacturing methods, 3D printing significantly improves control of microstructure features, such as the placement and connection of elements. As a result, variations in both the microstructure and associated properties of the auxiliary material are reduced as compared to conventional woven fabric auxiliary materials. For example, these three-dimensionally printed auxiliary materials can be structured to compress a predetermined amount with a substantially uniform substance. Also, fine control over the microstructure may allow the porosity of the auxiliary material to be adjusted to enhance tissue endoculture. In addition, these three-dimensionally printed auxiliary materials can be adapted for use with various staples and tissue types.

Generally, the auxiliary materials provided herein are designed and placed on top of the body, such as the cartridge body 402 in FIG. When the staples are fired (deployed) from the body, the staples penetrate the auxiliary material and into the tissue. When the staple legs are deformed relative to the anvil located on the opposite side of the staple cartridge assembly, the deformed legs capture a portion of the auxiliary material and a portion of the tissue within each staple. That is, when the staples are fired into the tissue, at least a portion of the auxiliary material is placed between the tissue and the fired staples. Auxiliary materials described herein may be configured to be attached to a stapler cartridge body, but herein the auxiliary materials are fitted with components of other instruments, such as the jaws of a surgical stapler. It is also intended that it may be configured to do so. Those skilled in the art will appreciate that the auxiliary materials provided herein can be used for reloading replaceable cartridges or staples that are not cartridge-based.

FIG. 6 shows an exemplary embodiment of a staple cartridge assembly 600 that includes a staple cartridge 602 and an auxiliary material 604. Other than the differences described in detail below, the staple cartridge 602 may be similar to the staple cartridge 400 (FIG. 4) and is therefore not described in detail herein. As shown, the auxiliary material 604 is arranged with respect to the staple cartridge 602. The staple cartridge can include the cartridge body 606 and a plurality of staples 608 arranged therein, as in the staples 406 shown in FIGS. 4 and 5. Staples 608 may include any suitable unmolded (pre-deployment) height. For example, staples 608 can have an unformed height of about 2 mm to 4.8 mm. Prior to deployment, the crown of staple 608 can be supported by staple 610.

In the illustrated embodiment, the auxiliary material 604 may be fitted to the outer surface 612 of the cartridge body 606, such as the tissue contact surface. In some embodiments, the outer surface 612 of the cartridge body 606 can include one or more mounting features. One or more mounting features are configured to engage the auxiliary material 604 to avoid unwanted movement of the auxiliary material 604 with respect to the cartridge body 606 and / or premature release of the auxiliary material 604 from the cartridge body 606. Can be done. An exemplary mounting feature can be found in US Patent Application Publication No. 2016/0106427, which is incorporated herein by reference in its entirety.

Auxiliary material 604 is compressible, allowing the auxiliary material to be compressed to various heights to compensate for the thickness of the different tissues trapped within the staples deployed. The auxiliary material 604 has an uncompressed (undeformed) or undeployed height and is configured to be deformed to one of a plurality of compressed (deformed) or deployed heights. For example, the auxiliary material 604 may have an uncompressed height that is higher than the firing height of the staples 608 (eg, the height (H) of the launched staples 608a of FIG. 7). That is, the auxiliary material 604 can have an undeformed state in which the maximum height of the auxiliary material 604 is higher than the maximum height of the fired staples 608a (ie, the staples in the molded configuration). In one embodiment, the uncompressed height of the auxiliary material 604 is about 10% higher, about 20% higher, about 30% higher, about 40% higher, about 50% higher than the firing height of the staple 608. It may be about 60% higher, about 70% higher, about 80% higher, about 90% higher, or about 100% higher. In certain embodiments, the uncompressed height of the auxiliary material 604 may be more than 100% higher than, for example, the firing height of the staple 608.

The auxiliary material 604 can be releasably fitted to the outer surface 612 of the cartridge body 606. As shown in FIG. 7, when the staples are fired, the tissue (T) and a portion of the auxiliary material 604 are captured by the fired (formed) staples 608a. Each of the fired staples 608a defines a capture area therein, as described above, to accommodate the captured auxiliary material 604 and tissue (T). The capture area defined by the fired staples 608a is, at least in part, limited by the height (H) of the fired staples 608a. For example, the height of the fired staple 608a can be about 0.160 inches or less. In some embodiments, the height of the first stapled 608a can be about 0.130 inches or less. In one embodiment, the height of the fired staples 608a can be from about 0.020 inches to 0.130 inches. In another embodiment, the height of the fired staples 608a can be from about 0.060 inches to 0.160 inches.

As mentioned above, the auxiliary material 604 can be compressed in multiple fired staples regardless of whether the thickness of the tissue trapped in the staples is the same or different within each fired staple. .. In at least one exemplary embodiment, the staples in a row of staples can be deformed to a firing height of, for example, about 2.75 mm, and the tissue (T) and auxiliary material 604 are compressed within this height. Can be done. In certain situations, the structure (T) can have a compression height of about 1.0 mm and the auxiliary material 604 can have a compression height of about 1.75 mm. In certain situations, the structure (T) can have a compression height of about 1.50 mm and the auxiliary material 604 can have a compression height of about 1.25 mm. In certain situations, the structure (T) can have a compression height of about 1.75 mm and the auxiliary material 604 can have a compression height of about 1.00 mm. In certain situations, the structure (T) can have a compression height of about 2.00 mm and the auxiliary material 604 can have a compression height of about 0.75 mm. In certain situations, the structure (T) can have a compression height of about 2.25 mm and the auxiliary material 604 can have a compression height of about 0.50 mm. Therefore, the sum of the compression heights of the captured tissue (T) and the auxiliary material 604 can be equal to, or at least substantially equal to, the height (H) of the launched staples 608a.

As discussed in more detail below, the structure of the auxiliary material resists the pressure of circulating blood through the tissue as the auxiliary material and tissue are captured in the fired staples. It can be configured so that the stresses that can be applied can be applied. Hypertension is usually considered to be 210 mmHg, so it is desirable that the auxiliary material apply a stress of 210 mmHg or more (eg, 3 g / mm ^{2) to the tissue for a given period (eg, 3 days).} Thus, in certain embodiments, the auxiliary material ^{may be configured to apply a stress of at least about 3 g / mm 2} to the captured tissue for at least 3 days. Auxiliary material is in a tissue-deployed state when the auxiliary material is stapled to tissue in vivo. In one embodiment, the applied stress can be about 3 g / mm ² . In another embodiment, the applied stress can be greater than 3 g / mm ² . In yet another embodiment, the stress may be at least about 3 g / mm ² and can be applied to the captured tissue for more than 3 days. For example, in one embodiment, the stress can be at least about 3 g / mm ² and can be applied to the captured tissue for about 3-5 days.

Hooke's law (F = kD) principles can be used to design auxiliary materials configured to apply a stress of at least about 3 g / mm ^{2 to the captured tissue for a given period of time.} For example, if the force (stress) applied to the captured tissue is known, the auxiliary material can be designed to have stiffness (k). Rigidity can be set by adjusting the geometry of the auxiliary material (eg, the diameter of the struts and / or the interconnectivity of the struts, eg, the angles and spaces between the struts). In addition, the auxiliary material can be designed to have the maximum amount of compressive displacement with respect to the minimum tissue thickness of the tissue, eg 1 mm, and thus the height of the given maximum staple. The length of the displacement D, when stapled to the tissue, eg, 2.75 mm, can be a combination of the minimum thickness of the tissue, eg 1 mm, and the thickness of the auxiliary material. As an example, in one embodiment, the auxiliary material has a height greater than the maximum formed stapled height of 2.75 mm and is stapled to a minimum thickness of 1 mm. It can be structured to compress to a height of .75 mm. Therefore, the auxiliary material has a constant rigidity (k) and total thickness (D) of the captured structure and the auxiliary material so that a stress of ^{3 g / mm 2 can be applied to the captured structure.} The compressibility can change to maintain the displacement D of length. It should be noted, for example, that those skilled in the art will understand that the above equation may be modified to take into account temperature fluctuations when attempting to bring the auxiliary material from room temperature to body temperature after implantation, for example.

In addition, the auxiliary material can be further developed to apply a substantially continuous stress to the captured tissue (eg, 3 g / mm ² ) over a predetermined time (eg, 3 days). To achieve this point, when designing the auxiliary material, it is necessary to consider the rate of decomposition of the material of the auxiliary material and the rate of in-growth of the tissue inside the auxiliary material. In doing so, the auxiliary material is designed so that the stiffness of the auxiliary material and / or the sum of the trapped tissue and auxiliary material thickness varies in a manner that can produce applied stresses of less than ^{3 g / mm 2.} You can avoid it.

Auxiliary materials are stapled to the tissue under various stapling conditions (eg, tissue thickness, height of molded staples, intra-tissue pressure). Depending on the stapled condition, the effective amount of stress required for the auxiliary material to be applied to the tissue and prevent the tissue from tearing or leaking can be determined. For example, in one embodiment, the effective amount of stress is at least about 3 g / mm ² . Because the auxiliary material exerts an effective amount of stress on the tissue, the auxiliary material can be designed to effectively supplement various staple fastening conditions. Therefore, the geometry of the auxiliary material can be adjusted to exhibit different compression heights when stapled to the tissue. Due to the finite range of intra-tissue pressure, tissue thickness, and height of the molded staples, they are stapled over a range of stapling conditions for a total of a given time (eg, at least 3 days). At that time, it is possible to determine the appropriate geometry of the auxiliary material, which may be effective in applying a substantially continuous desired stress to the structure (eg, 3 g / mm ^2). That is, as described in more detail below, the auxiliary material is made of a compressible material so that the auxiliary material can be compressed to various heights in a given plane when stapled to the structure. , Geometrically constructed. In addition, this varying response by the auxiliary material also causes the auxiliary material to tissue when exposed to fluctuations in tissue pressure that can occur when the auxiliary material is stapled to the tissue (eg, a sudden rise in blood pressure). It can be made possible to maintain a continuous application of the desired stress to the tissue.

Auxiliary materials can be manufactured by additional manufacturing, also known as 3D printing or 3D printing. 3D printing is a high-speed, additional manufacturing technique that allows the deposition of various types of materials in a printer-like manner. That is, 3D printing is achieved by laying layers of continuous material to form a shape. To print, the printer reads the model design from a digital file, lays a continuous layer of material, and builds a series of cross sections. These layers are joined or automatically melted to create the final shape when determined by the model. This technique makes it possible to create various shapes or geometric features with control and precision. As a non-limiting example of a suitable 3D printing process, also known as additional production, as classified by ASTM Committee 42, vat's liquid photopolymer is selectively cured by photoactivated polymerization. VAT photopolymerization (eg, stereolithography); material injection in which droplets of build material are selectively deposited; binder injection in which a liquid binder is selectively deposited to bond powder materials; thermal energy Powder bed diffusion (eg, selective laser sintering) that selectively melts areas of the powder bed; used to melt the material by melting the concentrated thermal energy as they are deposited. Direct energy deposition; the concentrated thermal energy is used to melt the material by melting when they are deposited; direct energy deposition; the material is selectively distributed through a nozzle or orifice. Extrusion of the material to be made (eg, melt deposition modeling); and a sheet laminate in which the sheets of the material are joined to form an object.

For example, in some embodiments, the method can include scanning the beam and melting multiple powder layers to form a compressible bioabsorbable auxiliary material. It is elongated with a tissue contact surface, a cartridge contact surface opposite the tissue contact surface, and a plurality of struts forming a geometric repeating unit extending between the tissue contact surface and the cartridge contact surface. Has a body. In one embodiment, the method may also include coating the auxiliary material with one or more antibacterial agents.

Auxiliary material can be formed from one or more matrices. In certain embodiments, the matrix may be in the form of a particulate matrix. In such situations, each particulate matrix can be formed from molten particles (eg, molten bioabsorbable polymer particles).

In general, each matrix can be formed from at least one molten polymer. At least one molten polymer can be selected to impart the desired compressibility to the auxiliary material. For example, in one embodiment the matrix comprises a molten polymer, while in other embodiments the matrix may comprise two or more different molten polymers. Alternatively or additionally, if the auxiliary material comprises two or more matrices, each matrix may be formed of the same molten polymer or different molten polymers of each other. For example, the first matrix can include a first molten polymer, and the second matrix can include a second molten polymer that is more or less flexible than the first molten polymer. In this way, the molten polymer can provide a variety of flexibility to the auxiliary material. In addition, the molten polymer can have different decomposition rates so that the compressibility of the auxiliary material can be adjusted over time as a function of the decomposition rate.

Various types of materials can be used, but in some embodiments, at least one molten polymer is a bioabsorbable polymer. Non-limiting examples of suitable bioabsorbable polymers include thermoplastic absorbent polyurethanes, UV curable bioabsorbable polyurethanes, poly (lactic acid) (PLA), polycaprolactone (PCL), polyglycolides, polydioxanone (PDS). , Poly (lactic acid-co-glycolic acid) (PLGA), polyglycolic acid, trimethylene carbonate, glycolide, dioxanone, polyester, any copolymers thereof, or any combination thereof. Further non-limiting examples of suitable bioabsorbable polymers include 3-terminal hydroxyl-terminated PCL or poly (DL-lactide), PLA-PEG or poly (trimethylene carbonate), PEG dimethyl or trimethyl modified with acrylate or methacrylate end groups. Acrylate or methacrylate, polypropylene fumarate, L-lactide / caprolactone copolymer, collagen infiltrated PLGA polymer, PCL-tricalcium phosphate (TCP), hyaluronic acid coated PLGA-TCP copolymer, PCL-PLGA-TCP, PLGA-PCL copolymers, PDS polymers and copolymers, PCL polymers and hyaluronic acid, collagen coated PCL and beta tricalcium phosphate, polyvinyl alcohol, calcium phosphate / poly (hydroxybutyrate-covalerate), and calcium hydroxyapatite / poly-L. -Includes macromers with lactide.

For example, in some embodiments, the auxiliary material can be formed from a variety of components, each formed of a matrix containing at least one molten bioabsorbable polymer. In some embodiments, the auxiliary material is fused with a first component formed from a first matrix of at least one melted bioabsorbable polymer (eg, polygrantin or polydioxanone) and at least one melted. It can have a second component formed from a second matrix containing a bioabsorbable polymer (eg, a polycaprolactone copolymer). At least one molten bioabsorbable polymer in each matrix can include at least two different bioabsorbable polymers. In one embodiment, the first component can have a first color and the second component can have a second color that is different from the first color.

In some embodiments, the auxiliary material can be drug elution. For example, one or more components of the auxiliary material may include a composition having a pharmaceutically active agent. The composition may release a therapeutically effective amount of the pharmaceutically active agent. In various embodiments, the pharmaceutically active agent can be released as the auxiliary material is desorbed / adsorbed. In various embodiments, the pharmaceutically active agent can be released into a liquid (eg, blood) that passes over or through its auxiliary material. Non-limiting examples of pharmaceutically active agents include hemostatic and hemostatic agents (eg, fibrin, thrombin, and oxidatively regenerated cellulose (ORC)); anti-inflammatory agents (eg, diclofenac, aspirin, naproxene, slindac, and hydrocortisone); antibiotics. Includes substances and antibacterial agents or antibacterial agents (eg, triclosan, ionic silver, ampicillin, gentamicin, polymyxin B, and chloramphenicol); and anticancer agents (eg, cisplatin, mitomycin, and adriamycin).

Auxiliary material can also include an external coating. The coating may be part of the 3D printing process or may be applied secondarily to the auxiliary material. For example, in some embodiments, the auxiliary material may be partially or completely coated with an antibacterial agent. Non-limiting examples of suitable antibacterial agents include triclosan, chlorhexidine, silver preparations (such as nanocrystalline silver), lauric acid alginate ethyl ester (LAE), octenidin, polyhexamethylene biguanide (PHMB), taurolysin; lactic acid, citrate. Includes acids, acetic acid, and salts thereof.

The auxiliary material or any component thereof may be at least partially coated with a bioabsorbable polymer different from at least one molten bioabsorbable polymer of the auxiliary material. In this way, one or more properties of the auxiliary material can be varied from the properties of its base material (eg, molten bioabsorbable polymer). For example, the auxiliary material can be coated with a bioabsorbable polymer that improves structural stability. Alternatively or additionally, the auxiliary material can be coated with a bioabsorbable polymer having a slower degradation rate compared to the degradation rate of at least one molten bioabsorbable polymer of the auxiliary material. .. In this way, the life of the auxiliary material can be extended without sacrificing the desired compressibility of the auxiliary material, which is at least partially provided by the at least one molten bioabsorbable polymer.

Auxiliary materials can have various configurations. In general, the auxiliary material may include a tissue contact surface, a body contact surface on the opposite side (eg, a cartridge contact layer), and an elongated body (structural layer) disposed between them. The tissue contact surface and the cartridge contact surface can have a structure different from the structural layer so as to form the tissue contact layer and the cartridge contact layer in a specific embodiment. In some embodiments, the elongated body is formed from a plurality of struts. The stanchions can have a variety of configurations, and in certain exemplary embodiments, the stanchions can form interconnected geometric repeating units.

In some embodiments, the tissue contact layer engages tissue located between the auxiliary material and the anvil so as to substantially prevent sliding movement of the tissue to the auxiliary material during staple fastening. It is possible to include a plurality of surface feature portions configured as described above. These surface features may also be configured to minimize sliding movement of the auxiliary material with respect to the tissue when the auxiliary material is stapled. These surface features can have various configurations. For example, the surface feature can extend at a distance of approximately 0.007 "to 0.015" from the tissue contact surface.

Further, in some embodiments, these surface features extend in a direction substantially lateral to the longitudinal axis (L) of the body, as in the cartridge body 606 of FIG. Can be done. In another embodiment, at least a portion of the surface feature can include a plurality of ridges and a plurality of grooves defined between the ridges. In yet another embodiment, these surface features extend at least upward from the body, inward towards the central groove, and distal towards the second end of the body. Can include a tread. Further details of the anti-slip mechanism in the form of ridges and grooves, or in the form of treads, can be found in US Patent Application Publication No. 2015/0034696, which is incorporated herein by reference in its entirety.

In some embodiments, the plurality of surface features can be configured to pull the tissue in opposite directions, thus counteracting resistance (to prevent the tissue from sliding during staple fastening). For example, lateral bias) is provided. For example, the tissue contact layer has a first plurality of surface features that can extend in a first direction and a second plurality of that can extend in a second direction different from the first direction. Can include a surface feature portion of. As a result, the first and second surface features can create tension between the surface features that actively prevent tissue movement in at least one direction. In one embodiment, the first plurality of surface features can extend in the first direction and the second plurality of surface features can extend in the opposite second direction. .. In such situations, these surface features may be configured to simultaneously pull the tissue in opposite directions.

Opposing resistance can also be created by surface warpage. For example, the tissue contact layer, or alternative, eg, the entire auxiliary material, may be designed to have an elastic convex shape, and the surface features may extend radially outward from the tissue contact layer. During use, as the surgical stapler anvil moves from the open position to the closed position, the tissue contact layer deforms (eg, is compressed into a substantially straight configuration), as described above, and the surface features become At this time, it extends substantially vertically outward from the tissue contact layer and can engage with the tissue. When the anvil returns to its open position, the tissue contact layer returns to its convex shape, creating surface tension between the surface features that simultaneously pull the engaged tissue in opposite directions.

On the other hand, in certain embodiments, it may be desirable for the tissue to slide in a predetermined plane during staple fastening. Thus, in some embodiments, the tissue contact layer facilitates sliding (eg, sliding movement) of the tissue in a first predetermined direction with respect to the auxiliary material, in a second direction different from the first direction. It may include surface features that may be designed to limit movement to. Alternatively or additionally, the tissue contact layer can be coated with a material to increase lubricity (eg, sodium stearate or alginate ethyl laurate ester).

As described above, the auxiliary material is arranged on the upper part of the main body as in the cartridge main body 606 (FIG. 6). The fixation of the auxiliary material to the body can be strengthened before and between the staples. For example, the body contact layer (eg, the cartridge contact layer) may include a surface feature configured to engage the body so as to substantially prevent the auxiliary material from sliding with respect to the body. These surface features can have various configurations. For example, in embodiments where the body includes mounting features, the body contact layer can have surface features in a recessed form configured to receive these mounting features. Other mounting features are described in more detail below.

As mentioned above, the elongated body can be formed from a plurality of struts. These struts can form geometric repeating units interconnected with each other. As discussed in more detail below, an array of struts and / or repeating units can be structurally configured to impart various compressibility to the auxiliary material, thus the auxiliary material is variable. It can have a stiffness profile. For example, the auxiliary material can have a first stiffness when compressed by a first amount and a second stiffness when compressed by a second amount. The second quantity may be larger than the first quantity and vice versa. Therefore, the stiffness of the auxiliary material can change as a function of compression. As described in more detail below, the greater the amount of compression, the greater the rigidity of the auxiliary material. Therefore, a single auxiliary material will be applied for at least a predetermined time (eg, 3 days) under various staple fastening conditions (eg, tissue thickness, height of molded staples, intra-tissue pressure). , Can be adjusted to provide a variety of responses to ensure that the minimum amount of stress is applied to the tissue (eg, 3 g / mm ^2). In addition, this varying response by the auxiliary material also preferably results in the minimum amount of stress applied (eg, 3 g / mm ² ) when the auxiliary material is stapled to the tissue and exposed to fluctuations in tissue pressure. Especially can be maintained.

These columns can be designed in various configurations. For example, these struts can produce a grid or truss-like structure as shown in FIGS. 8A-9C and 11A-15. A spiral-shaped structure as shown in FIG. 16 or a pillar as shown in FIGS. 17-19.

The geometry of the stanchions themselves, as well as the geometry of the repeating units formed from them, can control the movement of the auxiliary material in various planes. For example, the interoperability of struts allows the auxiliary material to be compressed in a first predetermined direction and may be configured to limit movement in a second direction different from the first direction. You can create a geometric unit. As described in more detail below, in some embodiments, the second direction may traverse the first predetermined direction. Alternatively or additionally, the geometric unit can be configured to limit the rotational movement of the auxiliary material about an axis perpendicular to the first predetermined direction.

In some embodiments, the stanchions may have a substantially uniform cross section, but in other embodiments, the stanchions may have a variety of cross sections. In addition, the strut material can also serve to define the movement of the auxiliary material in a given plane.

8A-9C and 11A-19 include a tissue contact surface, a cartridge contact surface opposite the tissue contact surface, and an elongated body formed by struts arranged between them. An exemplary auxiliary material is shown. Each exemplary auxiliary material is shown in partial form (eg, not the entire length), and thus those skilled in the art will appreciate that the auxiliary material is more in length, as specified in each embodiment. Understand that it may be long, i.e., along its longitudinal axis L. The length can vary based on the length of the staple cartridge. Furthermore, each of the exemplary auxiliary material, so that the longitudinal axis L of the auxiliary material extending along this in alignment with the longitudinal axis of the cartridge body (L _C), placed on top of the cartridge body It is configured to be. Each of these auxiliary materials can be formed from one or more matrices containing at least one molten bioabsorbable polymer. These auxiliary materials are structured to compress when exposed to compressive forces (eg, stress or load). As discussed in more detail below, these auxiliary materials are also designed to promote both tissue and cell endoculture.

8A-8B show exemplary embodiments of the auxiliary material 800 having a tissue contact surface 802, a cartridge contact surface 804 on the opposite side, and an elongated body 806. It is contemplated that the tissue contact surface 802, the cartridge contact surface 804, and the elongated body 806 can each be formed from different materials, but in this embodiment shown they are formed from the same molten bioabsorbable polymer. Has been done. That is, the auxiliary material 800 is formed of the same molten bioabsorbable polymer matrix.

As shown in FIG. 8A, the elongated body 806 includes a planar array 808 of repeating units 810 interconnected to each other at a junction or node 814. The repeating unit 810 is formed from a plurality of interconnected struts 816 having a first portion 818 and a second portion 820, respectively. A portion of the stanchion 816 can also include a third portion 821 that extends from each second portion and interconnects with each other to form a joint or node 814. As described in more detail below, the auxiliary material 800 can exhibit various stiffnesses and movements based on the amount and direction of stress applied during use. Therefore, the auxiliary material has a variable stiffness profile, and when the auxiliary material is stapled to the tissue, the auxiliary material is above the minimum stress threshold ^{for a predetermined time (eg, stress of 3 g / mm 2 in 3 days).} It can be configured to apply stress.

Further, as shown, the elongated body 806 includes a first planar array 808 of struts, an additional planar array 808 _N arranged parallel to each other, and a planar array 808 (eg, extending in the x direction). And include. In each of the arrays 808 _{, 808 N} , the stanchions 816 are substantially planar and extend in the same plane with each other in their respective planes. Further, each array 808, 808 _N can have various configurations, but in this embodiment shown, each array 808, 808 _N is substantially symmetrical with respect to an intermediate plane. That is, each array 808, 808 _N has two substantially identical rows 824a, 824b of the repeating unit 810.

The stanchions 816 can have various configurations, but in this embodiment, each stanchion 816 has a generally elongated planar configuration, and the first portion 818 of each stanchion 816 is of the second portion 820. It has a narrower width than the width part. As a result, the stanchions 816 are wide in the center, preferably along most of the length, and narrower at the ends. Alternatively, the first portion 818 can have a cross section equal to or greater than the cross section of the second portion 820. Further, as shown in FIG. 8B, the second portion 820 of each strut 816 can have a substantially rectangular cross-sectional shape. It should be noted that other cross-sectional shapes of the stanchions and some of them are also contemplated herein. The cross-sectional shape of the stanchion can be used to limit the movement of the auxiliary material in a particular direction.

In FIG. 8A, the struts 816 are interconnected with each other at the ends of their first portion 818 to form a junction or node 822. In the embodiments shown, the stanchions 816 and the joints or nodes 822 can be made of the same material. Therefore, in order to enhance the compression of the auxiliary material 800 under stress, the cross section of the first portion 818, also referred to as the neck down region, can be bent as described in more detail below. Furthermore, the third portion 821 of each strut 816 is structured similarly to the first portion 818 of the strut 816, and thus this third portion 821, also referred to as the neck down region, is also described below. Can be bent, as in the details.

The material of the joint or node 822 to the stanchion 816 (eg, more flexible or less flexible) partially controls the amount and / or direction in which the auxiliary material 800 moves under stress during use. be able to. Similarly, the material at the joint or node 814 can partially control the amount and / or direction in which the auxiliary material 800 moves under stress during use. The joints or nodes 814, 822 can be of any suitable shape. For example, in certain embodiments, the junction or nodes 814, 822 may be in the form of ball-shaped features. In other embodiments, the joints or nodes 814, 822 can take the form of other geometric shapes.

The stanchions 816 can be interconnected with each other at various angles. For example, in this embodiment shown, the stanchions 816 intersect an adjacent stanchion 816 at an angle of about 90 degrees. In other embodiments, the stanchions 816 can intersect at an angle in the range of about 40 degrees to 130 degrees. In another embodiment, the stanchions 816 can intersect at an angle in the range of about 10 degrees to 90 degrees. The angle at which the struts 816 connect to each other can, at least in part, control the way and amount the auxiliary material 800 responds under stress. That is, the movement and stiffness of the auxiliary material 800 can be, at least in part, a function of these angles.

As mentioned above, the first portion 818 (and the third portion 821, if any) of each strut 816 can serve as a flexible region (eg, deflection point) for the auxiliary material. .. The first portion 818 of each strut provides each repeating unit 812 with one or more bending zones, as shown in FIGS. 9A-9C. That is, these neck-down regions allow the struts 816 to bend around or adjacent to the joint or node 822 when the auxiliary material 800 is under stress, thus the repeating unit 810 Can be partially or completely crushed on themselves. Similarly, the neck-down region forming the third portion 821 allows the repeating unit to bend around or adjacent to the joint or node 814 when the auxiliary material is under stress. Therefore, the compressibility of the auxiliary material 800 can vary based on different amounts and directions of stress applied. This change in compressibility may be desirable, for example, when the auxiliary material is stapled to the tissue and exposed to fluctuations in tissue pressure.

9A-9C show the compressive behavior of one repeating unit 810 of the auxiliary material 800 described herein under different stresses. Specifically, the repeating unit 810 is in a pre-compressed (undeformed) state in FIG. 9A, a _{first compressed state under a first} stress (S 1) in FIG. 9B, and a second in FIG. 9C. It is shown in the second compressed state (C) under stress (S _2). Therefore, the repeating unit 810, and thus the auxiliary material 800, has a variable stiffness profile under different stresses. Those skilled in the art will appreciate that the height of deployment of the auxiliary material may vary throughout its use, and the height of deployment is a function of the particular stress applied to the auxiliary material throughout its use, at least in part. Understand that.

As shown in FIG 9A~ Figure 9B, when repeating unit 810 therefore the auxiliary member 800, in FIG. 8A is below the first stress _{S 1,} a first portion 818 (e.g., neck-down region of each strut 816 ) Can be bent around the joint or node 822. Thereby, the repeating unit 810 can be compressed from the pre-compressed state (FIG. 9A) to the first compressed state (FIG. 9B), so that the auxiliary material 800 is first from the pre-compressed height. Compressed to the height of the deployment. Further, depending on the amount of stress applied to the auxiliary material, the second portion 820 of the adjacent struts 816 can come into contact with each other. This is shown in FIG. 9B. Therefore, in such a situation, the first portion 818 of each strut 816 has reached a maximum deflection point that creates a higher stiffness resistance within the repeating unit 810. This is because the stiffness of the repeating unit 810, and thus the auxiliary material 800, increases as the auxiliary material 800 compresses. FIG. 10 is an exemplary graph representation of the relationship between compression and stiffness of the auxiliary material. Therefore, any further compression of the repeat 810, and thus the auxiliary material 800, requires additional applied stress.

Larger stress (e.g., a second stress, S ₂₎ is, in a situation that applies to repeating units 810 thus adjunct 800, in Figure 8A, it is possible to overcome the increase in stiffness resistance. To achieve this, the stanchions 816 may be configured such that the struts 816 can be further bent about a joint or node 822 when additional stress is applied. As shown in FIG. 9C, this further bending causes the strut 816 to expand further outward in the lateral (L) direction and in the direction of the applied stress, thereby causing a second of the adjacent strut 816. The portions 820 can further contact each other. As a result, the repeating unit 810 can be compressed to a second compressed state (FIG. 9C), and thus the auxiliary material 800 can be compressed to the height of the second deployment.

In some embodiments, the auxiliary material may include additional components that can prevent the movement of tissue stapled to the auxiliary material. For example, FIGS. 11A-11B show an exemplary auxiliary material 1100 that includes a plurality of surface features 1128 defined within the tissue contact layer 1102. As described in more detail below, the surface feature portion 1128 can prevent the auxiliary material from sliding movement with respect to the tissue stapled to the auxiliary material. In one embodiment, at least a portion of the surface feature portion 1128 can prevent lateral sliding of the auxiliary material 1100 with respect to the tissue. Alternatively or additionally, at least a portion of the surface feature portion 1128 can prevent the auxiliary material 1100 from sliding in the longitudinal direction with respect to the tissue.

The exemplary auxiliary material 1100 shown includes a tissue contact layer 1102 and a cartridge contact layer 1104 on the opposite side. Auxiliary material 1100 also includes an elongated body 1106 having a plurality of struts 1116 extending between the tissue contact layer 1102 and the cartridge contact layer 1104. As shown, the tissue contact layer 1102 includes a plurality of surface feature portions 1128a and 1128b defined therein. These surface features 1128 extend longitudinally (eg, parallel to the longitudinal axis of the auxiliary material) with a first series 1128a extending laterally (eg, across the longitudinal axis of the auxiliary material). It has a grid pattern with a second series 1128b. Each surface feature portion 1128a, 1128b can have a triangular outline angled with respect to each other, or at least two surfaces, so that they together penetrate the tissue and engage the tissue. Form the edges. These edges can collectively define the outermost surface of the tissue contact layer 1102. These surface feature portions 1128a, 1128b can engage with the tissue when the tissue is compressed into the tissue contact layer 1102 as a result of the auxiliary material being stapled to the tissue. The orientation of the edges of the first series 1128a can prevent lateral sliding of the auxiliary material with respect to the tissue, and the orientation of the edges of the second series 1128b is the longitudinal direction of the auxiliary material 1100 with respect to the tissue. Sliding can be prevented. Further, the tissue contact layer 1102 includes a plurality of openings 1144 formed between these surface feature portions 1128. In this way, the plurality of openings 1144 can accept the tissue when the auxiliary material is stapled to the tissue to allow the surface feature 1128 to engage with the tissue.

Although the plurality of columns 1116 can be interconnected to form various configurations, in this embodiment shown, the plurality of columns 1116 form a repeating X-shaped pattern. Specifically, the plurality of columns 1116 form a repeating cubic unit. Each cubic unit includes a top surface 1130 and a contralateral bottom surface 1132. In this embodiment shown, the top and bottom surfaces 1130 and 1132 are substantially identical. The Kubit unit also includes four side surfaces 1134 that extend between the top and bottom surfaces 1130 and 1132 and connect them. In this embodiment shown, side 1134 is substantially identical. For clarity, not all surfaces of each indicated cubit unit have been identified in FIGS. 11A-11B. The side surfaces 1134 can have various shapes, for example, as shown, and each side surface 1134 has an X-shape extending from the top surface 1130 to the bottom surface 1132. Therefore, the first end of each strut 1116, 1116a terminates at the tissue contact layer 1102, and the second end of each strut 1116, 1116a terminates at the cartridge contact layer 1104. Each X can be formed by two elongated, substantially flat struts that intersect at the midpoint. Further, each repeating cube unit can also include an internal strut extending between the two opposite sides 1134 of the cube unit to form an inner connection feature 1138. As shown, the inner connection feature 1138 can extend from the top 1134a of one side surface 1134 to the bottom 1134b of the opposite side surface 1134. As further shown, the inner connection feature 1138 can extend between adjacent cubic units in alternating directions. For example, as shown in FIG. 11B, the first inner connection feature 1138 may have an upper end 1138a extending from the upper 1134a of one side surface 1134 to the lower end 1138b of the bottom 1134b of the opposite side surface 1134. Adjacent cubic units can have a second inner connection feature 1138 having a lower end 1138c extending from the same bottom 1134b on the side surface 1134 to the upper end 1138d at the upper end 1134c on the opposite side surface 1134. The inner connection feature 1138 can provide the auxiliary member 1100 with a geometric shape capable of facilitating the movement of the auxiliary member 1100 in a predetermined direction under the applied stress. For example, in one embodiment, the inner connection feature 1138 can substantially prevent shearing of the auxiliary material 1100 under applied stress.

Each column, as well as the interconnect feature 1138, may have various configurations, but in this embodiment shown, the columns 1116, 1116a and the interconnect feature 1138 are, respectively, from depth (D). Also in the form of beams or columns with a large width (W), which allows each column / interconnect feature to be in and out of a plane extending along the width (W). Limited to flexion. Further, the columns 1116, 1116a and the interconnect feature 1138 can each include at least one opening 1140 extending through it to facilitate bending in a predetermined direction. For clarity, all openings 1140 extending through each strut 1116 and interconnect feature 1138 are not specified in FIGS. 11A-11B. These openings 1140 can have various shapes, for example, as shown, and these openings 1140 are in the shape of diamonds. It is also contemplated that the shape of the opening 1140 can vary between struts. The opening 1140 can also be aligned over the auxiliary material. For example, openings extending longitudinally through opposite side walls that are longitudinally spaced along the length of the auxiliary material of adjacent cubic units can be longitudinally aligned and similarly adjacent. The openings extending laterally across the opposing side walls, which are laterally spaced along the width of the auxiliary material of the cube unit, can be aligned laterally.

Alternatively or additionally, the auxiliary material may include a connecting member that connects at least a portion of the joint or node to each other, thereby increasing the rigidity of the auxiliary material. That is, the connecting member can be incorporated into the auxiliary material so as to prevent the auxiliary material from moving (for example, spreading outward) on the plane on which the connecting member extends.

For example, FIGS. 12A-12B show exemplary embodiments of auxiliary material 1200 with connecting member 1246. Specifically, the auxiliary material 1200 includes an elongated body 1206 formed from a plurality of struts 1216 interconnected at joints or nodes 1222. The elongated body 1206 has a tissue contact surface 1202 and a cartridge contact surface 1204 on the opposite side. As shown, at least a portion of these joints or nodes 1222 are interconnected with each other by connecting members 1246. In this embodiment shown, the connecting member 1230 extends in a first direction (eg, the y direction shown in FIG. 12) and the stanchions 1216 are in a second direction different from the first direction (eg, the y direction shown in FIG. 12). For example, it extends in the transverse direction, for example, about 45 degrees with respect to the y direction shown in FIG. Therefore, the position of the connecting member 1246 with respect to the support column 1216 is configured to prevent the auxiliary member 1200 from moving in at least one direction (for example, a direction parallel to the direction in which the connecting member 1246 extends). The resulting geometric shape can be provided.

In some embodiments, the joint or node may be made of a material different from that of the strut. For example, the material of the joint or node can be made more flexible than the material of the strut, thereby increasing the compressibility of the auxiliary material. In addition, more flexible joints or nodes can also allow the auxiliary material to compress with virtually no shear. This is because the more flexible joints or nodes provide preferential bending zones for the auxiliary material, thereby reducing the stiffness of the auxiliary material. In one embodiment, the junction or node can be made of polycaprolactone copolymer and the struts can be made of polygrantin or polydioxanone.

13A-13B show another exemplary embodiment of auxiliary material 1300, including repeating units 1310 interconnected with each other at joints or nodes 1314. Each repeating unit 1310 is formed from a plurality of stanchions 1316, for example four stanchions, interconnected at a junction or node 1322. Apart from the differences described in detail below, the auxiliary material 1300 may be similar to the auxiliary material 800 (FIG. 8A) and is therefore not described in detail herein. In this embodiment shown, the joints or nodes 1314, 1322 are made of a material different from that of the stanchions 1316. The material of the joints or nodes 1314, 1322 may be more flexible than the material of the stanchions 1316. As shown, each junction or node 1314, 1322 is in the form of a rod 1348 extending over _{all arrays 1308, 1308 N in} a direction approximately perpendicular to the plane on which the struts extend. Good (eg, the rod can extend in the x direction as shown in FIGS. 13A-13B). That is, when the auxiliary material 1300 is attached to the cartridge body, the rod 1348 can extend laterally with respect to the longitudinal axis of the cartridge body, as in the cartridge body 606 of FIG.

In some embodiments, as shown in FIGS. 13A-13B, the ends of the first portion 1318 of the stanchions 1316 may also be directly connected to each other within the junction or node 1322. Alternatively or additionally, the ends of the third portion 1321 of the stanchions 816 may also be directly connected to each other within the joint or node 1314. This direct connection can help prevent the stanchion 1316 from being pulled out of the joint or node 1322 when the stanchion 1316 bends when the auxiliary material 1300 is under stress. As a result of this direct connection, bending of one strut can also affect another bending. Further, as compared to the joint or node 822 of FIG. 8A, these joints or nodes 1322 may be more flexible and therefore more compatible, so that the auxiliary material 1300 may be the auxiliary material 800. Can be compressed more easily compared to. Therefore, under the same given stress, the auxiliary material 1300 achieves a larger displacement (ie, compression to a lower deployment height) compared to the auxiliary material 800 of FIG. 8A.

Alternatively, the stanchions may not be connected to each other within the joint or node, for example, as shown in FIG. For brevity only, FIG. 14 shows a single iteration unit 1400. In this embodiment shown, the stanchions 1416 are not directly connected to each other within a junction or node 1422. As a result, bending of one strut can occur independently of bending of another strut. Each strut 1416 is configured to maintain a connection to the junction or node 1422 in order to prevent the strut 1416 from being pulled out of the joint or node 1422 as the strut 1416 bends around it. It can have a part shape of 1450. Moreover, as compared to the junction or node 1322 of FIGS. 13A-13B, this junction or node 1422 can be more flexible and therefore more compatible, and therefore various repeating units 1400. The auxiliary material formed in can be more easily compressed under a given stress. That is, under the same given stress, the auxiliary material having this strut and joint or node configuration shown has a larger displacement (ie, that is, compared to the auxiliary material 800 of FIGS. 13-13A. Compression to lower heights) can be achieved.

In some embodiments, the auxiliary material can also include at least one stopping element configured to limit the amount of compression of the auxiliary material. FIG. 15 shows an exemplary embodiment of auxiliary material 1500 having at least one stopping element 1552. Other than the differences described in detail below, the auxiliary material 1500 may be similar to the auxiliary material 1300 (FIGS. 13A-13B) and is therefore not described in detail herein.

In FIG. 15, each strut 1516 may have a stop element 1552 extending from or adjacent to the surface of its second portion 1520. When the auxiliary material 1500 is compressed, the stanchions 1516 can bend around the joints or nodes 1514, 1522 until the stop elements 1552 come into contact with each other. When these stop elements 1552 abut against each other, any further bending of the stanchions 1516 is prevented. That is, these stop elements 1552 act as anti-deflections that allow the auxiliary material 1500 to compress to the height of the first deployment with first stiffness under a given stress. Upon reaching the height of the first compression, the stop element 1552 extends to the bottom to prevent further deflection of the stanchions 1516 and thus prevent further compression of the auxiliary material 1500. As the stop element 1552 extends to the bottom, more stress needs to be applied to cause further bending of the stanchions 1516 around the joints or nodes 1514, 1522, and thus further compression of the auxiliary material 1500. ..

Although various stopping elements 1552 are shown in FIG. 15, it should be noted that it is contemplated herein that fewer or additional stopping elements may be included throughout the auxiliary material 1500. Moreover, the shape, size, and position of the stop element 1552 is not limited by this embodiment shown and can therefore be varied to control the desired amount of compression.

As mentioned above, the elongated body can include a plurality of struts that can have various shapes. For example, FIG. 16 shows an exemplary auxiliary material 1600 having an elongated body 1606 including a plurality of struts 1616 that are substantially spiral in shape. Therefore, each geometric repeating unit is in the form of a spiral or coil. In this embodiment, the elongated body 1606 is disposed between the tissue contact layer 1602 and the cartridge contact layer 1604. As shown, each of the layers 1602, 1604 is a substantially planar solid layer with an opening 1626. At least a portion of these openings 1626 is aligned with the openings 1615 defined by each strut 1116. The thickness of each layer can vary. The stanchions 1616 are configured to have a predetermined compression height in order to limit the amount of compression of the auxiliary material. Further, considering their shape, these struts 1616 may be configured to function as springs. Therefore, as with the spring constant, each strut 1616 can be given a particular stiffness based on its shape. Therefore, the compressibility of the auxiliary material 1600 may also depend on the particular stiffness of each strut 1616, which depends on both the material and shape of the strut 1616.

As shown in FIGS. 8A, 11A-13B, and 15-16, the respective auxiliary materials 800, 1100, 1200, 1300, 1500, 1600 have openings 826, 1140, 1144, 1226, 1326, respectively. 1526, 1626 can be included. These openings can be configured to promote cell infestation within each auxiliary material. The opening can define the void content of the auxiliary material. In some embodiments, the void content can be from about 15% to 95%, while in other embodiments the void content can be from about 75% to 90%. As used herein, "opening" is used synonymously with "void." In addition, the auxiliary material can have a surface area to volume ratio of about 1: 100 to 1: 5. In some embodiments, the auxiliary material may have a surface area to volume ratio of about 1:10.

The openings can also be located inside the various components of the auxiliary material. Each opening may have dimensions that extend, at least partially, through the components. In certain embodiments, openings 826, 1140, 1444, 1226, 1326, 1526, 1615, 1626 are tissue contact surfaces or, as shown in FIGS. 8A, 11A-13B, and 15-16. It can be present inside a layer, a cartridge contact surface or layer, and / or an elongated body. In these embodiments shown, these openings extend completely through their respective components. Inside the elongated body, these openings can be defined by interconnected struts. In addition, these openings may also be interconnected over auxiliary materials, thereby forming a substantially continuous network of openings or channels. Further, as shown in FIGS. 11A-11B, the opening 1126 may also be present inside the inner connection feature 1138.

The openings can have various sizes and / or shapes. For example, a larger opening can allow tissue (and cells) to penetrate the auxiliary material, while a smaller opening allows the tissue (and cells) to penetrate the auxiliary material, while smaller openings promote cell endoculture. Can capture cells. In this way, the variable size of the openings across the auxiliary material can facilitate extracellular remodeling. That is, the variable size of the openings can promote angiogenesis and migration of cells inside the auxiliary material when implanted, thereby promoting tissue and cell endoculture. Both can be encouraged. In addition, the variable size of the openings can also facilitate the extraction of implanted auxiliary materials and thus by-products and cellular waste products from the implantation site. In some embodiments, the openings are substantially circular in shape.

For example, in embodiments where the openings are located within a tissue contact surface or layer and elongated body, as in FIGS. 8A, 11A-13B, and 15-16, the openings are, respectively, 4-4. It can have a diameter that is about 70% to 170% of the diameter of the staple leg of the staple, such as the staple 406 of 5. The openings in the tissue contact surface and in the elongated body can have various sizes. For example, in some embodiments, the openings in the tissue contact surface may each have a diameter in the range of about 100 μm to 1000 μm. In one embodiment, each opening on the tissue contact surface can have a diameter of at least about 14 μm. Each elongated body opening can have a diameter in the range of about 200 μm to 610 μm, or about 400 μm to 1000 μm. As used herein, the "diameter" of an opening is the maximum distance between any pair of vertices of the opening.

Further, in some embodiments, an opening in a tissue contact surface or layer is such that one or more portions of the tissue penetrate or compress into the tissue contact surface or layer (eg, openings 1144, 1226, 1626). It can be configured to make it possible. In this way, as described above, when the auxiliary material is stapled to the tissue and the tissue is compressed inside the opening, the slidable movement of the auxiliary material with respect to the tissue can be substantially prevented. ..

In other embodiments, the auxiliary material may be configured to enhance the advancement of the staple legs through the auxiliary material. For example, the auxiliary material can have an opening that aligns with the advancing direction of the staple legs and partially penetrates the auxiliary material. The opening can extend partially or completely through the auxiliary material. Thus, as the staple legs advance through the auxiliary material, the opening can serve as a guide to minimize damage to the staple and the auxiliary material as the staple passes.

In some embodiments, the auxiliary material can include a plurality of columns in the form of columns, as shown in FIGS. 17-19. For example, in FIG. 17, the columns are substantially vertical and may be of various heights. Furthermore, in other embodiments, as shown in FIG. 19, the set of first columns may be substantially vertical and the set of second columns may be curved. The stanchions can be made of the same or different materials. In some embodiments, the auxiliary material can include a first plurality of struts made of the first material and a second plurality of struts made of the second material.

In FIG. 17, auxiliary member 1700 includes a plurality of columns 1716 in the form of substantially vertical columns. Specifically, these struts 1716 extend from the cartridge contact layer 1704, and in some cases towards the opposing tissue contact layer 1702. The plurality of columns 1716 has a first plurality of vertical columns 1716a _{having a first} height (Y) and a second having a second height (Y 1) less than the first height (Y). It includes a plurality of columns 1716b and a third plurality of columns 1716c having a _third height (Y _{3) less than a second height (Y 2).} For brevity, only a portion of the plurality of columns 1716 is shown in FIG. Although not shown, those skilled in the art will appreciate that the tissue and / or cartridge contact layers 1702, 1704 may include openings as discussed herein.

The various heights of these plurality of columns 1716 can provide various compressibility to the auxiliary material. 18A-18C show the compressive behavior of the auxiliary material 1700 under different stresses. Specifically, the auxiliary material 1700 is the pre-compressed height of FIG. 18A, the first compression height (H _{1 ) under the first} stress (S 1) of FIG. 18B, and FIG. 18C. It is indicated by the height of the second compression (H _{2 ) under the second} stress (S 2). As shown, the height of the first compression (H ₁ ) is higher than the height of the second compression (H ₂ ), so the first stress (S ₁ ) is the second stress (S 1). It is smaller than _{S 2).} It is noted that the auxiliary material may vary in compression height throughout its use, and that the compression height is, at least in part, a function of the particular stress applied to the auxiliary material throughout its use. The vendor understands.

As shown in FIGS. 18A-18C, as the compression of auxiliary material 1700 increases, the amount of stress required to achieve such compression increases. This is because as the auxiliary material 1700 compresses, additional struts are engaged, which increases the stiffness resistance of the auxiliary material 1700. For example, the first stress _{S 1} applied to the auxiliary material 1700, as shown in FIG. 18B, the first and second plurality of struts 1716a, 1716B are engaged. By comparison, when the auxiliary member 1700 is under the second stress _{S 2,} first, second, and third plurality of struts 1716a, 1716b, 1716c is engaged, thereby a higher stiffness resistance produce.

FIG. 19 shows another exemplary embodiment of auxiliary material 1900 having a plurality of columns 1916 in the form of substantially vertical columns 1916a or curved columns 1916b. The substantially vertical column 1916a is configured to support the initial stress applied to the auxiliary material 1900 and then deflect or buckle as the auxiliary material compresses (eg, at deflection point D in FIG. 20). Can be done. The curved column 1916b can be configured to provide approximately constant stiffness (ie, essentially the offset of all curves shown in FIG. 20 from the zero axis). This mechanical behavior of the stanchions 1916, and thus the auxiliary material 1900, is graphically illustrated in FIG.

In other embodiments, the auxiliary material may include additional features. The figure below shows the features that may be included in any of the auxiliary materials disclosed herein, and thus does not show the specific configuration of the auxiliary material, i.e. the configuration of the repeating unit. FIG. 21A shows an embodiment of an auxiliary material 2100 having an internally formed channel 2108 configured to receive a cutting element such as a knife.

As shown in FIG. 21A, the auxiliary material 2100 includes a first portion 2104 and a second portion 2106 having outer and inner edges, respectively. The inner edges 2104a and 2106a define a channel 2108 extending between the first and second portions and along the longitudinal axis (L) of the auxiliary member 2100. Channel 2108 is configured to receive cutting members such as knives. As shown in FIG. 121B, the channel 21 does not extend completely through the height of the auxiliary material 2100. In particular, channel 2108 does not extend through the cartridge contact surface 2110. In this way, the auxiliary material 2100 is configured to have sufficient structural integrity, thereby being effectively manipulated and attached to a cartridge body such as the cartridge body 2214 of FIG. 21B. During use, when the cutting member is first fired and moves along the auxiliary material, the cutting member cuts the channel, thereby separating the first and second parts, thus separating the auxiliary material 2100 into two separate parts. Separate into parts.

Further, as shown in FIG. 21A, the auxiliary material 2100 includes a flange 2112 configured to fit into the cartridge body 2214 of FIG. 21B, as will be further described below. FIG. 21A shows an auxiliary material 2100 having a flange 2112 on one side of the auxiliary material 2100, but an additional flange 2112 may be on the opposite side of the auxiliary material 2100. Those skilled in the art will appreciate that the number and arrangement of flanges 2112 is not limited to those shown in FIG. 21A. The flange 2112 can be made of a variety of materials, but in some embodiments, the flange 2112 can be an extension of the cartridge contact surface 2110, as shown in FIG. 21A. Those skilled in the art will appreciate that flanges can be formed in-line with auxiliary materials (eg, as part of a 3D printing process) or offline formed alternatives and then secondarily applied to auxiliary materials. To do.

FIG. 21B shows an embodiment of the staple cartridge assembly 2200. Other than the differences described in detail below, the staple cartridge assembly 2200 may be similar to the staple cartridge assembly 600 (FIG. 6) and is therefore not described in detail herein. Furthermore, for brevity, the specific components of the staple cartridge assembly 2200 are not shown in FIG. 21B.

The staple cartridge assembly 2200 includes an auxiliary material 2100 of FIG. 21A attached to the cartridge body 2214. Auxiliary material 2100 can be attached to the cartridge body 2214 using any suitable method, as described in more detail below. In this embodiment, the cartridge body 2214 includes a recessed channel 2216 configured to receive the auxiliary material flange 2112 so that the flange 2112 can engage the surface of the cartridge body 2214. In this way, the auxiliary material 2100 is more firmly attached to the cartridge body, thereby preventing unwanted movement of the auxiliary material 2100 in use.

In another embodiment, as shown in FIG. 22, the auxiliary material 3000 can have a channel 3008 having one or more openings 3010 extending (eg, perforated) through it. At least one cross-linking member 3012 is created by. Therefore, the first and second portions 3014, 3016 of the auxiliary material 3000 are selectively connected by at least one cross-linking member 3012. During use, when the cutting member is first fired and moves along the auxiliary member 3000, the cutting member cuts at least one bridging member 3012, thereby separating the first and second portions 3014, 3016. Thus, the auxiliary material 3000 is separated into two separate parts.

In some embodiments, the cartridge body, such as the cartridge body 2214 of FIG. 21B, and the auxiliary material, such as the auxiliary material 3000 of FIG. 22, have the auxiliary material as the cutting element moves through the auxiliary material 3000. Complementary reinforcing features that may be configured to prevent tearing outside the channel can be included. For example, the reinforcing feature of the cartridge body can be a cylindrical recessed opening located close to a slot in the cartridge body, and the reinforcing feature of the auxiliary material can be at least one crosslinked member. It can be a cylindrical protrusion placed in close proximity to the inside of the first and second portions of the auxiliary material. In this way, when the auxiliary material is placed on top of the cartridge body, these cylindrical protrusions of the auxiliary material extend into these recessed openings in the cartridge body. It is also contemplated that these protrusions and recessed openings can take the form of various other shapes.

The scaffold can be applied to the cartridge body and any suitable method can be used to form the staple cartridge assembly. For example, in some embodiments, the method may include attaching a compressible bioabsorbable aid to the cartridge body of a surgical stapler. In one embodiment, as described above, attaching the auxiliary material to the cartridge body brings the cartridge contact surface of the auxiliary material to the surface of the cartridge body in order to insert the flange of the auxiliary material into the recessed channel of the cartridge body. It may include placing against. In another embodiment, the method may also include coating the surface of the cartridge body with an adhesive before attaching the auxiliary material to the cartridge body.

The devices disclosed herein can be designed to be discarded after a single use, or can be designed to be used multiple times. However, in either case, the device can be readjusted for reuse after at least one use. The readjustment can include any combination of a disassembly step of the device, a subsequent cleaning step or a replacement step of a particular part, and a subsequent reassembly step. In particular, the device can be disassembled and any number of specific parts or parts of the device can be selectively replaced or removed in any combination. After cleaning and / or replacing certain parts, the device can be reassembled either at the readjustment facility or by the surgical team just prior to the surgical procedure for later use. Those skilled in the art will appreciate that readjustment of the device can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques, and the resulting readjusted devices, are all within the scope of this application.

One of ordinary skill in the art will recognize further features and advantages of the invention based on the embodiments described above. Therefore, the present invention is not limited to the contents specifically shown and explained, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety. Any patent, publication or information incorporated herein by reference in whole or in part is inconsistent with any existing definition, description, or other disclosure material set forth in this document. It is incorporated herein only to the extent that it does not. Accordingly, the disclosures expressly set forth herein shall supersede any contradictory literature incorporated herein.

[Implementation mode]
(1) Staple fastening assembly for use with surgical staplers
A body having a plurality of staples arranged internally, the plurality of staples being configured to be deployed within the tissue, the body being the first end, the second end, and theirs. With the body, which has a longitudinal axis extending in between,
A three-dimensional compressible auxiliary material, wherein the auxiliary material is formed from a matrix containing at least one molten bioabsorbable polymer so that the auxiliary material can be attached to a tissue by the plurality of staples in the main body. The auxiliary material is configured to be releasably held on the body, and the auxiliary material has a plurality of struts that are interconnected at a joint to form a lattice structure having a plurality of openings inside. The interoperability of the plurality of stanchions with the joint allows the auxiliary material to be compressed in a first predetermined direction and moves in a second direction different from the first predetermined direction. A stapled assembly that includes auxiliary materials, which form a geometric shape that is configured to limit.
(2) The stapled assembly according to embodiment 1, wherein the joint is more flexible than the plurality of struts.
(3) The stapled assembly according to embodiment 1, wherein each of the plurality of struts has a substantially rectangular cross-sectional shape configured to limit movement in the second direction.
(4) The stapled assembly according to embodiment 1, wherein the second direction traverses the first predetermined direction.
(5) In the first embodiment, the geometric shape is configured to limit the rotational movement of the auxiliary material about the axis of the auxiliary material perpendicular to the first predetermined direction. Described staple assembly.

(6) The first embodiment, wherein the plurality of stanchions include a first stanchion, each of which is substantially flat, and the first stanchions extend on the same plane as each other in the first plane. Staple fastening assembly.
(7) The plurality of stanchions include a second stanchion, each of which is substantially a plane, the second stanchion extends on the same plane as each other in the second plane, and the second plane is The stapled assembly according to embodiment 6, parallel to the first plane.
(8) The auxiliary material has a tissue contact surface and a main body contact surface opposite to the tissue contact surface, and the tissue contact surface and the main body contact surface face each other in the first predetermined direction. The stapled assembly according to embodiment 1.
(9) The stapled assembly according to embodiment 1, wherein the staple assembly comprises a plurality of connecting members in which the auxiliary members connect at least a portion of adjacent joints to each other to increase the rigidity of the auxiliary materials.
(10) The stapled assembly according to embodiment 1, wherein each joint comprises a ball-shaped feature.

(11) The auxiliary material is configured to apply a stress ^{of at least about 3 g / mm 2 to} the tissue stapled to the auxiliary material for at least 3 days when the auxiliary material is in a tissue-deployed state. The stapled assembly according to embodiment 1.
(12) Staple fastening assembly for use with surgical staplers.
A main body having a plurality of staples arranged inside and configured so that the plurality of staples are deployed in an organization.
A three-dimensional compressible auxiliary material, wherein the auxiliary material is formed from a matrix containing at least one molten bioabsorbable polymer so that the auxiliary material can be attached to a tissue by the plurality of staples in the main body. A plurality of repeating units having a geometric shape configured to be releasably held on the body and the auxiliary material configured to facilitate unidirectional compression of the auxiliary material. Staple fastening assembly, with auxiliary material, with struts.
(13) The stapled assembly according to embodiment 12, wherein the plurality of struts are interconnected at nodes and the repeating units form a lattice structure.
(14) The staple fastening according to embodiment 13, wherein the plurality of columns are formed of a first material, and the nodes are formed of a second material that is more flexible than the first material. assembly.
(15) The stapled assembly according to embodiment 12, wherein the plurality of struts are substantially spiral in shape.

(16) The stapled assembly according to embodiment 12, wherein each strut comprises a neck-down region configured to bend so that the auxiliary material can be compressed.
(17) A connecting member extending in the same plane as the plurality of columns is further provided, and the connecting member is configured to limit the movement of the auxiliary material in the transverse direction with respect to the compression in the one direction. The stapled assembly according to embodiment 12.
(18) The 12th embodiment, wherein the plurality of stanchions include a first stanchion, each of which is substantially flat, and the first stanchions extend on the same plane as each other in the first plane. Staple fastening assembly.
(19) The plurality of stanchions include a second stanchion, each of which is substantially flat, and the second stanchion extends on the same plane as each other in the second plane, and the second plane is The stapled assembly according to embodiment 18, which is parallel to the first plane.
(20) The auxiliary material is configured to apply a stress ^{of at least about 3 g / mm 2 to} the tissue stapled to the auxiliary material for at least 3 days when the auxiliary material is in a tissue-deployed state. The stapled assembly according to embodiment 12.

Claims (20)

Staple fastening assembly for use with surgical staplers
A body having a plurality of staples arranged internally, the plurality of staples being configured to be deployed within the tissue, the body being the first end, the second end, and theirs. With the body, which has a longitudinal axis extending in between,
A three-dimensional compressible auxiliary material, wherein the auxiliary material is formed from a matrix containing at least one molten bioabsorbable polymer so that the auxiliary material can be attached to a tissue by the plurality of staples in the main body. The auxiliary material is configured to be releasably held on the body, and the auxiliary material has a plurality of struts that are interconnected at a joint to form a lattice structure having a plurality of openings inside. The interoperability of the plurality of stanchions with the joint allows the auxiliary material to be compressed in a first predetermined direction and moves in a second direction different from the first predetermined direction. A stapled assembly that includes auxiliary materials, which form a geometric shape that is configured to limit. The stapled assembly of claim 1, wherein the joint is more flexible than the plurality of struts. The stapled assembly of claim 1, wherein each of the plurality of struts has a substantially rectangular cross-sectional shape configured to limit movement in the second direction. The stapled assembly according to claim 1, wherein the second direction traverses the first predetermined direction. The staple according to claim 1, wherein the geometric shape is configured to limit the rotational movement of the auxiliary material about the axis of the auxiliary material that is perpendicular to the first predetermined direction. Staple assembly. The stapled assembly according to claim 1, wherein the plurality of stanchions include a first stanchion, each of which is substantially planar, and the first stanchions extend in the same plane as each other in the first plane. .. The plurality of stanchions include a second stanchion, each of which is substantially planar, the second stanchion extends in the same plane as each other in the second plane, and the second plane is said first. The stapled assembly according to claim 6, which is parallel to the plane of. The auxiliary material has a tissue contact surface and a main body contact surface opposite to the tissue contact surface, and the tissue contact surface and the main body contact surface move toward each other in the first predetermined direction. , The stapled assembly according to claim 1. The stapled assembly of claim 1, wherein the staple assembly comprises a plurality of connecting members in which the auxiliary members connect at least a portion of adjacent joints to each other to increase the rigidity of the auxiliary materials. The stapled assembly of claim 1, wherein each joint comprises a ball-shaped feature. The auxiliary material is configured to apply a stress ^{of at least about 3 g / mm 2 to} the tissue stapled to the auxiliary material for at least 3 days when the auxiliary material is in a tissue-deployed state. The stapled assembly according to item 1. Staple fastening assembly for use with surgical staplers
A main body having a plurality of staples arranged inside and configured so that the plurality of staples are deployed in an organization.
A three-dimensional compressible auxiliary material, wherein the auxiliary material is formed from a matrix containing at least one molten bioabsorbable polymer so that the auxiliary material can be attached to a tissue by the plurality of staples in the main body. A plurality of repeating units having a geometric shape configured to be releasably held on the body and the auxiliary material configured to facilitate unidirectional compression of the auxiliary material. Staple fastening assembly, with auxiliary material, with struts. The stapled assembly of claim 12, wherein the plurality of struts are interconnected at nodes and the repeating units form a lattice structure. 13. The stapled assembly of claim 13, wherein the plurality of struts are made of a first material and the nodes are made of a second material that is more flexible than the first material. 12. The stapled assembly according to claim 12, wherein the plurality of struts are substantially spiral in shape. 12. The stapled assembly of claim 12, wherein each strut comprises a neck-down region configured to bend so that the auxiliary material can be compressed. A claim that further comprises a connecting member extending in the same plane as the plurality of struts, the connecting member being configured to limit the transverse movement of the auxiliary material with respect to the compression in one direction. Item 12. The stapled assembly. 12. The stapled assembly according to claim 12, wherein the plurality of stanchions include a first stanchion, each of which is substantially planar, and the first stanchions extend in the same plane as each other in the first plane. .. The plurality of stanchions include a second stanchion, each of which is substantially planar, the second stanchions extending in the same plane as each other in the second plane, and the second plane being said first. 18. The stapled assembly according to claim 18, which is parallel to the plane of. The auxiliary material is configured to apply a stress ^{of at least about 3 g / mm 2 to} the tissue stapled to the auxiliary material for at least 3 days when the auxiliary material is in a tissue-deployed state. Item 12. The stapled assembly.

Images